(178 days)
The neoClose device is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic/ laparoscopic surgery.
The neoClose device is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic surgery. There are two neoClose product codes, neoClose Hasson and neoClose Universal, each consisting of an AccuGuide and two AutoAnchors loaded onto two Drivers. The neoClose Hasson is designed to provide sealed anchoring of a laparoscopic trocar and suture placement for subsequent soft tissue approximation. The neoClose Universal is equivalent to the neoClose Hasson design in its method of soft tissue approximation but does not provide for sealed anchoring of a trocar. Soft tissue approximation is facilitated by delivering two AutoAnchors, through an AccuGuide with a Driver. The AutoAnchors and Drivers for both the neoClose Hasson and Universal are identical but the AccuGuides differ in construction. The Hasson AccuGuide features Suture Locks, a flexible Sleeve, and two Guide Channels while the Universal AccuGuide features a Thumb Grip and one Guide Channel.
The provided text describes a 510(k) summary for the neoClose device, which is a suture passer for endoscopic/laparoscopic surgery. However, the document does not contain the specific details required to answer your request about acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/human reader study.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document broadly refers to "at least as safe and effective as the predicate devices."
- Reported Device Performance: The document states that "Design Verification bench testing and an acute GLP Animal Study support the performance of the neoClose device and demonstrates that it is at least as safe and effective as the predicate devices." No specific quantitative performance metrics (e.g., tensile strength, closure time, success rate) are provided or compared against defined acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified, beyond mentioning "Design Verification bench testing and an acute GLP Animal Study." The country of origin for the animal study is not mentioned, nor is whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. The studies mentioned (
Design Verification bench testingandGLP Animal Study) do not involve human expert interpretation in the way an AI diagnostic device study would. The performance appears to be assessed via scientific and clinical endpoints in animal models and bench tests.
4. Adjudication Method for the Test Set
- Not applicable. See point 3.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve With AI vs. Without AI Assistance
- No, an MRMC study was not done. This device is a surgical tool, not an AI-assisted diagnostic device. The documentation focuses on equivalence to a predicate device through bench and animal testing, not on human reader performance with or without AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- For bench testing: Likely engineering specifications, physical measurements, and possibly simulated clinical conditions.
- For the GLP Animal Study: Clinical and pathological observations in an animal model. The specific endpoints or "ground truth" (e.g., successful tissue approximation, absence of complications, healing outcomes) are not detailed.
8. The Sample Size for the Training Set
- Not applicable. This device does not use machine learning, so there is no training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
In summary: The provided 510(k) summary is for a physical surgical device and discusses its substantial equivalence to a predicate device through bench and animal testing. It does not provide the kind of information requested regarding AI performance, human reader studies, or detailed acceptance criteria with quantitative results, as would be expected for an AI/ML-based diagnostic device.
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APR 1 8 2013
510(k) Summary For neoClose Device
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the neoClose Device
| 510(k) Number | K123280 |
|---|---|
| Date Prepared | 19 October 2012 |
| Proprietary Name | neoClose Hasson and neoClose Universal |
| Common Name | Suture passer |
| Classification Name | §876.1500 Product code GCJEndoscope and Accessories. |
| Device Classification | Class II |
| Device Panel | General and Plastic Surgery Devices |
| Predicate Device | Carter-Thomason CloseSure System® |
| Submitter | neoSurgical Ltd.Block 12Galway Technology Park,Parkmore,Galway,IrelandPh: +353 (0)91 421 000 |
| Contact Person | Orla BrennanBlock 12Galway Technology Park,Parkmore,Galway,IrelandPh: +353 (0)91 421 000 |
Device Description
The neoClose device is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic surgery. There are two neoClose product codes, neoClose Hasson and neoClose Universal, each consisting of an AccuGuide and two AutoAnchors loaded onto two Drivers.
The neoClose Hasson is designed to provide sealed anchoring of a laparoscopic trocar and suture placement for subsequent soft tissue approximation. The neoClose Universal is equivalent to the neoClose Hasson design in its method of soft tissue approximation but does not provide for sealed anchoring of a trocar. Soft tissue approximation is facilitated by delivering two AutoAnchors, through an AccuGuide with a Driver. The AutoAnchors and Drivers for both the neoClose
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K123280 Page 2/2
Hasson and Universal are identical but the AccuGuides differ in construction. The Hasson AccuGuide features Suture Locks, a flexible Sleeve, and two Guide Channels while the Universal AccuGuide features a Thumb Grip and one Guide Channel.
Intended Use
The neoClose device is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic/ laparoscopic surgery.
Summary of Technological Characteristics of Current Device Compared to the Predicate Device
The technical characteristics of the applicant device are substantially equivalent to the predicate device(s) with respect to indications for use, product design, materials, packaging, labeling and sterilization methods.
Support of Substantial Equivalence
neoSurgical has submitted information on indication for use, design and principle of operation, biocompatibility and performance characteristics to establish that the neoClose device is substantially equivalent to the currently marketed predicate devices. A detailed justification for substantial equivalence was completed which includes a side-by-side comparison of the product attributes of the applicant device and predicate devices. Design Verification bench testing and a GLP Animal Study support the performance of the neoClose device and demonstrates that it is at least as safe and effective as the predicate devices.
- Intended Use . The neoClose components have the same intended use as the predicates.
- . Physical Characteristics
There are no significant technological differences between the neoClose device and predicate devices affecting intended use or safety and effectiveness.
. Anatomical Sites
The neoClose device and its predicates may be utilized in the same anatomical site.
- . Performance
Design Verification bench testing and an acute GLP Animal Study support the use of the neoClose device and demonstrate that it is at least as safe and effective as the predicate devices.
Safety Characteristics .
The GLP Animal Study demonstrated that the safety and effectiveness of the neoClose and the primary predicate device, the Carter-Thomason CloseSure System®, are substantially equivalent.
The neoClose device is substantially equivalent to the predicate devices since it has the same intended use, does not raise new concerns regarding safety and effectiveness and is at least as safe and effective as the predicate devices when used in accordance with the Instructions for Use.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and health. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
April 18, 2013
neoSurgical, Ltd. % Orla Brennan Director, Quality Assurance & Regulatory Affairs Block 12, Galway Technology Park Parkmore, Galway, Ireland
Re: K123280
Trade/Device Name: neoClose Hasson, neoClose Universal Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class 2 Product Code: GCJ Dated: March 13, 2013 Received: March 25, 2013
Dear Orla Brennan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
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Page 2 - Orla Brennan
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, FOR
Peter Di Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
| 510(k) Number: | K123280 |
|---|---|
| Device Name: | neoClose |
| Indications for Use: | The neoClose device is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic/ laparoscopic surgery. |
Prescription Use__X Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krause
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123280
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§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.